A. FIELD OF THE INVENTION
This invention relates to devices that apply external, non-invasive, compression to treat nosebleeds and a method for using those external compression devices to treat anterior nosebleeds.
B. DESCRIPTION OF PRIOR ART
1.) Treatment of Nosebleeds
Nosebleeds may occur in the anterior (front) or posterior (back) area of the nasal passage. The treatment of posterior nosebleeds is exclusively internal and invasive, and is usually done in the emergency room or operating room by a physician specializing in the treatment of ear, nose and throat problems.
Anterior nosebleeds are usually treated at home and only 8 to 10% are serious or recurrent enough to require professional medical attention. The treatment of anterior nosebleeds can be divided into two methods: (a) internal or invasive methods, and (b) external or non-invasive methods.
a.) Internal Treatment
Internal treatment of anterior nosebleeds includes the use of three primary methods: vasoconstricting drugs, cautery, and insertion of various materials or devices to expedite clotting.
i.) The first internal treatment method is the use of vasoconstriction drugs instilled by spray bottle, atomizer, cotton pledget, or internal nosebleed clip. Vasoconstriction compounds include phenylephrine, oxymetozaline, epinephrine or cocaine, which act by causing the blood vessels in the nose to decrease in diameter and thus reduce blood flow. Kern (U.S. Pat. No. 4,457,756) disclosed an internal nosebleed clip with cotton pads that can be saturated with a vasoconstricting agent and inserted into the nostril(s). The clip exerts gentle pressure from inside the nose which can be augmented by finger pressure on the external portions of the clip or on the external surfaces of the tip of the nose.
ii.) The second internal treatment method is the use of cautery, which is the process of burning, and can be effected by chemical, electrical, or thermal means. Chemical cautery involves the touching of the bleeding site with silver nitrate sticks for 10 to 15 seconds. This treatment cannot stop bleeding, but is applied only after the bleeding has stopped to prevent re-bleeding. Overzealous use has caused septal perforations. Electrical cautery uses electrical energy to coagulate the bleeding area and is used almost exclusively by ear, nose and throat specialists. Thermal cautery uses a battery powered disposable device but it is difficult to control or estimate the depth of cautery achieved with these devices. Serious damage to the delicate nasal tissues can occur.
iii.) The third internal treatment method is insertion of various materials and devices into the nasal cavity to expedite clotting. All existing techniques involve the insertion of materials or other devices into the nasal cavity and the application of pressure either internal or external to stop bleeding. The materials used include petroleum-impregnated gauze, absorbent-cotton gauze, synthetic sponge, balloon devices, and thrombogenic agents. Pressure may be applied internally-specifically, by inserting a sufficient amount of packing material to apply pressure itself, by expansion of the sponge material when it contacts nasal fluids, by inflation of a balloon or, pressure may be applied externally, to cause an internal material to contact the bleeding nasal surfaces. These internal methods may use pressure alone or may be combined with an agent such as absorbent-cotton or thrombogenic chemical to expedite clotting. Absorbent-cotton has fine fibers that hold liquid blood adjacent to the bleeding vessel until a clot is formed thereby stopping bleeding. Thrombogenic chemicals also act to promoting clotting by enhancing the conversion of fibrinogen to fibrin.
Baer (U.S. Pat. No. 3,349,771) used absorbent-cotton placed inside the nose and a nasal clamp placed on the outside of the nose to force the bleeding areas of the nose into tight contact with the absorbent-cotton. Kern used an internal nosebleed clip to deliver vasoconstricting agents directly to the nasal mucosa. Neither of these internal treatment methods were widely adopted, as they still required insertion of material into the nasal cavity, with the attendant problems and risks of such internal treatment discussed herein.
Insertion of petroleum-impregnated gauze or absorbent-cotton is also painful and requires subsequent removal that may restart bleeding. Furthermore, it is difficult for internal packing to be inserted with sufficient uniformity to apply constant and evenly distributed pressure to the entire anterior nasal septum. There are many commercial products that have been designed to make the pressure more uniform, the insertion faster, more convenient and less uncomfortable for the patients. For example, the Merocel.RTM. (a product and trademark of the Merocel Corp., Mystic, Conn.) nasal sponge is a dehydrated, synthetic sponge-like material that expands upon contact with moisture. In addition, balloon devices can be inserted into the nasal cavity and inflated with air.
All of the above internal treatment methods, because of their inherent invasive nature, suffer from the disadvantages of causing the patient to suffer discomfort, possibly injuring the delicate nasal tissues, and in many cases requiring the services of a trained medical professional. Even with these disadvantages, the internal techniques are still not as effective as applying external pressure alone directly to the external nose.
b.) External Treatment
As opposed to internal treatment methods, exclusively external treatment is non-invasive and involves the application of pressure to the outside of the nose. External treatment of nosebleeds is the most effective way to apply pressure to the blood vessels in the nasal septum. Traditionally, the recommended technique is to have the patient use his own hand to apply pressure to the entire elastic area of the nose, using what is referred to as the "closed hand technique." To do so, the radial aspect of the index finger between the proximal and distal interphalangeal joints rests against the side of the nose and the thumb is used to exert pressure to the opposite side of the nose. The patient's arm and elbow are rested on the chest to help maintain the proper position. This technique is recommended because it reduces the risk that the patient will loosen his or her grip. A watch or clock should confirm the duration of compression for 5 to 10 minutes because patients invariably underestimate the amount of time that has elapsed.
In simple terms the nose is pinched between the thumb and index finger for 5 to 10 minutes. If properly and consistently applied for the recommended duration, this method can be effective for treating simple anterior nosebleeds. However, in practice its effectiveness is diminished because of the difficulty in maintaining constant pressure for even the minimum time period required (5 minutes). It is especially problematic in children because it must be done by the parent or other adult.
There are no known devices presently available that are designed to treat nosebleeds solely by the application of external pressure to the nose, which is an object of this invention.
2.) The Existing Use of a Noseclip Devices
An existing noseclip devices apply external compression to effect closure of the nostrils for the purposes of preventing water from entering the nostrils during swimming, performing respiratory function testing and delivering breathing treatments. Swimming noseclips pinch the inferior aspect of the nose to cause closure of the nostrils thus preventing the entry of water. In its existing respiratory use the noseclip is placed on the nose for the purpose of stopping the flow of air through the nasal passages. This closure causes air to move only through the mouth. Thereby, all the breathing air moves from the lungs through the mouth to an external respiratory measuring machine (respirometer) or breathing machine. This allows accurate measurement of lung volumes and flow or delivery of air, oxygen and/or medication.
Swimming noseclips are plastic U-shaped devices that are placed on the nose usually from the inferior aspect. Commercial noseclips are available (Swimline Nose Pinch, Edgewood, N.Y. and Future Way Corp., Floral Park, N.Y.). Existing respiratory noseclips are made of flexible plastic in the shape of a clothespin, and typically include some type of "pad" on the end of the inside surface that contacts the nose in order to reduce patient discomfort and enlarge the area of compression. Soft plastic, rubber, foam, sponge, or other soft materials are used to form the pads. There are numerous commercially available respiratory noseclips (Warren E. Collins, Inc., Braintree, Mass.; Vacumed, Ventura, Calif.; A-M System, Inc., Everett, Wash.) which vary in their shape and pad design (FIGS. 1A, 1B, 1C). The device is operated by squeezing the upper connecting arms 10 (FIG. 1C) between the thumb and first finger with force 11 sufficient to causes the lower connecting arms 12 to open 13 sufficiently wide to be placed on the nose.
C. The Problem
Nosebleeds occur in both adults and children, but are especially common in children. There is a need for a non-invasive treatment for this problem that is effective and yet safer than internal, invasive methods, and that can and will be administered by the patient or, if the patient is a child, by the child's parent, without the need for trained medical personnel. The invention must deliver uniform pressure to the entire soft portions of the external nose rather than just pinch the inferior aspect as with the swimmers noseclip. The invention described herein is designed to fulfill these needs. The inventor is an emergency medicine physician who has developed a new use of the existing respiratory noseclip device, a method for use of an external compression device to treat nosebleeds, and who has designed an anatomically conforming device to more effectively and comfortably provide such compression, all as described in this patent.
Ten percent of the American population has had at least one or more episodes of nosebleeds. Most of these are in children. Common causes of nosebleeds in children include picking the nose, nasal dryness, and minor trauma. The bleeding soils clothing, bedding, and furniture and is inconvenient. For the parents and children, bleeding represents a distressing occurrence.
In adults there is a small (and in children a very rare) but important percentage of nosebleeds which are located in the back (posterior) portions of the nasal passage and are serious, requiring urgent medical attention. The external compression device and method described in this patent are not for use in such patients.
Internal treatment of nosebleeds is invasive, painful, and usually requires medical professionals. Parents are generally unwilling to insert anything into their child's nose because of their concern over the discomfort it causes and the not unreasonable fear of injury to the child. Even adults are reluctant to insert these devices into their own noses for the same reasons and because it is difficult to self-administer objects such as a dry sponge, gauze, or internal clip into the sensitive nasal mucosa.
The existing closed hand (finger-thumb) method of external treatment of nosebleeds requires uniform pressure delivered continuously by hand for 5 to 10 minutes to an adult or child. This method is difficult to apply and tiring in practice, although if properly applied it can be effective.
D. The Object
The object of this invention is to provide an effective, safe, painless, non-invasive, exclusively external device, and a method for using such a device, which automatically delivers continuous, uniform pressure to the entire pliable lateral aspect of the lateral walls of the nose to treat simple anterior nosebleeds, without the need for treatment by trained medical personnel. This treatment can place pressure directly on the bleeding vessel, thereby typically causing cessation of the flow of blood and allowing the body's normal coagulation process to control the bleeding. This treatment can be accomplished with the use of the existing respiratory noseclip or, preferably, the new anatomically conforming noseclip described herein.